Metformin Versus Insulin in Pregnant Women With Type 2 Diabetes

Completed · Not applicable

Conditions studied: Pregnancy Complications

In brief

Pregnant women with type 2 diabetes mellitus (T2DM) are at increased risk for miscarriages, birth defects, large infants, and stillbirths. Maintaining blood sugars in the normal range decreases these pregnancy complications. We hypothesize that metformin will achieve similar levels of blood sugar control compared to insulin. In doing so, metformin will prevent the increased risk of pregnancy complications associated with T2DM in pregnancy. We propose a pilot study of a randomized, controlled trial of metformin versus insulin in the treatment of T2DM during pregnancy.

Key facts

Study ID

NCT00678080

Run by

The University of Texas Health Science Center, Houston

People needed

25

Starts

2008-09-01

Expected to finish

2011-08-01

Last updated by the study team

2018-11-28

Who can join

Age: 18 and older, up to 52. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• The onset of T2DM for less than 10 years prior to the onset of pregnancy by patient history
• Treatment with diet or oral hypoglycemic agents prior to pregnancy.
• Pregnancies less than 20 weeks of pregnancy. This gestational age was chosen to include those women who initiated prenatal care in the second trimester, but still have the ability to improve their hemoglobin A1C (primary outcome) with medical therapy prior to delivery.
• Newly diagnosed diabetes in the first 20 weeks of pregnancy. These women likely have had diabetes prior to the onset of pregnancy. They do not qualify for the diagnosis of gestational diabetes which is typically made after 20 weeks of pregnancy. Diagnosis will be made based on an elevated fasting blood glucose greater than 105 mg/dL, a 50 gram glucola result greater than 200 mg/dL or an abnormal 3 hour glucola test prior to 20 weeks of pregnancy. An abnormal 3-hour glucola test is defined as 2 out of 4 abnormal values.
• Hemoglobin A1C <9%

You may not qualify if…

• Gestational age greater than 20 weeks
• Multiple gestations (twins or more gestations)
• Type 1 diabetes by patient history
• Known fetal chromosomal or structural defects
• Contraindications to the use of metformin including renal disease, liver disease, prior myocardial infarction or sepsis.
• Those with a hemoglobin A1C greater than 9%.
• On insulin at the start of pregnancy

Where it is running

• Valley Baptist Hospital — Brownsville, Texas, United States
• Lyndon B Johnson Hospital — Houston, Texas, United States
• Memorial Hermann Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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